Pulmonary Hypertension of NewbornNCT05703191
A Real-world Study of Nitric Oxide Generator and Delivery System
An observational study of Pulmonary Hypertension of Newborn, run by Novlead Inc. at 1 site in China.
Trial summary
The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension of Newborn
- What is being tested?
- Nitric Oxide Generator and Delivery System
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newborns
Who may be able to join
- Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
- Admitted to the Department of Neonatology at the hospital, gender unlimited
- Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
- Documented Oxygenation index (OI) ≥8 prior to the treatment
- Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study
Who cannot join
- Proven risks of nitric oxide contraindication
- Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation
- Other circumstances that investigators believe unsuitable for enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangzhou
Bin Wang
About this study
Official title: The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.
- Conditions
- Pulmonary Hypertension of Newborn
- Being tested
- Nitric Oxide Generator and Delivery System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide Generator and Delivery SystemDevice
Initial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects.
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide | Inhaled Nitric Oxide Receives: Device: Nitric Oxide Generator and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Oxygenation Index (OI)
OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)
Measured: Baseline, Minutes 45
Secondary outcomes (6)
Change From Baseline in Oxygenation Index (OI)
OI = MPAW×100×FiO2/PaO2
Measured: Baseline, Hour 24, 2 hours after iNO is discontinued
Change From Baseline in Oxygen Saturation
Oxygen Saturation: Peripheral Capillary Oxygen Saturation (SpO2)
Measured: Baseline, Hour 24, 2 hours after iNO is discontinued
Change From Baseline in Pulmonary Artery Pressure (PAP)
Doppler echocardiography is used to detect the regurgitation velocity, and tricuspid regurgitation V values are derived. PAP = 4 × V2 + 5 mmHg.
Measured: Baseline, Hour 24, 2 hours after iNO is discontinued
Percentage of subjects responding to iNO
Responding to iNO is defined as a decrease in OI of 25% or more
Measured: Hour 24, 2 hours after iNO is discontinued
Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment
Parameters detected by Nitric Oxide Generator and Delivery System
Measured: Minutes 45, Hour 24, 2 hours after iNO is discontinued
Adverse events
Incidence of adverse events=Number of subjects with adverse events/Total number of subjects in treatment
Measured: Baseline up to 24 hours after iNO is discontinued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start3 Feb 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novlead Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Wang, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703191
- Sponsor's protocol ID
- PAH22-09
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study
- ClinicalTrials.gov ID
- NCT05703191
- Acronym / sponsor ID
- PAH22-09
- Conditions
- Pulmonary Hypertension of Newborn
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Novlead Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide | – | Device: Nitric Oxide Generator and Delivery SystemInhaled Nitric Oxide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborns
Key inclusion criteria (5 listed)
- Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
- Admitted to the Department of Neonatology at the hospital, gender unlimited
- Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
- Documented Oxygenation index (OI) ≥8 prior to the treatment
- Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study
Key exclusion criteria (3 listed)
- Proven risks of nitric oxide contraindication
- Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation
- Other circumstances that investigators believe unsuitable for enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric Oxide Generator and Delivery SystemInitial at 20ppm is recommended by guidelines. The concentration is adjusted based on actual condition of subjects. | Device | Nitric Oxide |
Primary outcome
Change From Baseline in Oxygenation Index (OI)
Time frame: Baseline, Minutes 45
OI = Mean Airway Pressure (MPAW)×100×Fraction of Inspiration Oxygen (FiO2)/Partial Pressure of Oxygen (PaO2)
6 secondary outcomes
Change From Baseline in Oxygenation Index (OI)
Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued
Change From Baseline in Oxygen Saturation
Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued
Change From Baseline in Pulmonary Artery Pressure (PAP)
Time frame: Baseline, Hour 24, 2 hours after iNO is discontinued
Percentage of subjects responding to iNO
Time frame: Hour 24, 2 hours after iNO is discontinued
Ventilation and monitoring parameters of Nitric Oxide Generator and Delivery System during treatment
Time frame: Minutes 45, Hour 24, 2 hours after iNO is discontinued
Adverse events
Time frame: Baseline up to 24 hours after iNO is discontinued
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin Wang principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension of Newborn, run by Novlead Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou Fang (+8615655595707, zhou.fang@novlead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Oxygenation Index (OI) (time frame: Baseline, Minutes 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.